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TBG Cementless Hip Stem, Ti coating
EUDAMEDClass III (EU MDR)
Ref 130250005SRef 130240004SRef 130230003SRef 130220002SRef 130270007S
Identity
- Device Name
- TBG Cementless Hip Stem, Ti coating EUDAMED
- Model / Reference
- 130250005S EUDAMED130240004S EUDAMED130230003S EUDAMED130220002S EUDAMED130270007S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06902139302168 EUDAMED06902139302151 EUDAMED06902139302144 EUDAMED06902139302137 EUDAMED06902139302182 EUDAMED
- Basic UDI-DI
- B-06902139302168 EUDAMEDB-06902139302151 EUDAMEDB-06902139302144 EUDAMEDB-06902139302137 EUDAMEDB-06902139302182 EUDAMED
- EMDN Code
- P090804010202 UNCEMENTED FEMORAL STEMS FOR PRIMARY IMPLANT, WITH FIXED NECK, ANATOMICAL EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Croatia EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
TBG Cementless Hip Stem, Ti coating by Double Medical Technology Inc. — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06902139302168 | Class III | Active |
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Manufacturer
- Manufacturer
- Double Medical Technology Inc.
- EUDAMED SRN
- CN-MF-000009048
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (5)
- EUDAMED e7bdb02a-7ce5-4179-9842-f186a56e4141 61 fields · synced Jul 27, 2026
- EUDAMED a8970223-cd76-477e-b37e-d69abb5b5170 61 fields · synced May 18, 2026
- EUDAMED 60822da9-2b9f-475e-ab9f-b668fbe92de3 61 fields · synced May 18, 2026
- EUDAMED 2ba897b5-79cd-488b-99cc-79890c636f82 61 fields · synced May 18, 2026
- EUDAMED 9b6e5c82-370a-4b70-ac6d-f66438d3ddf7 61 fields · synced May 19, 2026